Hepatitis D Virus (HDV) IgM Antibody, EIA [35664X]

Test Code

CPT Codes

Preferred Specimen
1 mL serum collected in a red-top tube (no gel)

Minimum Volume
0.5 mL

Transport Container
Plastic screw-cap vial

Transport Temperature
Refrigerated (cold packs)

Specimen Stability
Room temperature: 7 days
Refrigerated: 14 days
Frozen: 30 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Hemolyzed • Visibly hyperlipemic • Icteric • Suspected contaminated samples must be avoided as they could generate false results • Body fluids other than serum are not acceptable

Immunoassay (IA)

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Wed, Sat a.m.; Report available: 2-6 days

Reference Range

Interpretive criteria
Negative Antibody not detected
Positive Antibody detected

HDV infection occurs only in association with HBV infection. Acute HDV infection reflects either HDV acquisition at the time of acute HBV infection (coinfection), or recent exposure to HDV in a patient with chronic HBV infection (superinfection). HDV antigen is detected transiently during the early phase of acute HDV infection, but typically disappears as HDV-specific antibodies arise.

Clinical Significance
Hepatitis D Virus (HDV) infection occurs in association with HBV infection. A positive result for HDV IgM indicates recent HDV infection.

Performing Laboratory
Quest Diagnostics Infectious Disease, Inc.
33608 Ortega Highway, Bldg B-West Wing
San Juan Capistrano, CA 92675-2042

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.